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RecruitingNCT05672368Updated Apr 20, 2026

The da Vinci Single Port Robotic System for Use in Abdominal and Pelvic Surgical Procedures

A Phase 2 interventional study of Robot-Assisted Surgery in Disease or Disorder, sponsored by City of Hope Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by City of Hope Medical Center · Phase 2, Interventional, and Device feasibility

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 5 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This phase II trial test the effectiveness and safety of a single-port robotic device (the da Vinci single port [SP]1098) for use in abdominal and pelvic surgeries. The da Vinci SP1098 robotic device can be used to perform less invasive surgeries that allow entry into the body through a single, small incision. The use of this device during surgery may allow surgeons to perform complex procedures that result in less pain, fewer complications and side effects, and improved recovery.

Read the detailed description

PRIMARY OBJECTIVE:

I. To evaluate the effectiveness and safety for abdominal and pelvic procedures of a single-port robotic device (da Vinci SP1098) that is Food and Drug Administration (FDA)-approved for other indications, specifically urological and transoral otolaryngology surgical procedures.

OUTLINE:

Patients undergo surgery using the da Vinci SP1098 robotic system on study.

02

Conditions studied

  • Disease or Disorder

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03

In context

Disease

1,327 studies on the registry are indexed under Disease; 596 are open to participants now.

This study's planned enrollment of 33 is below the median of 80 across 732 interventional studies indexed under Disease.

Browse Disease studies →

Lead sponsor

City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Documented informed consent of the participant and/or legally authorized representative
  • Any patient scheduled to undergo robot-assisted abdominal or pelvic procedures
  • Age > 18 years

Exclusion criteria

Exclusion Criteria:

  • Body mass index (BMI) > 45
  • Contraindications to minimally invasive surgery including chronic obstructive pulmonary disorders
  • Past history of failed attempt of minimally invasive abdominal or pelvic surgery
05

Study design

Phase
Phase 2
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (estimated)

Study arms

  • Experimental
    Device feasibility (da Vinci SP1098 robotic system)

    Patients undergo surgery using the da Vinci SP1098 robotic system on study.

    Device: Robot-Assisted Surgery

Interventions

  • DeviceRobot-Assisted Surgery

    Undergo surgery using the da Vinci SP device

    Also known as: Navigation and Robotics, Robot Assisted, Robotic Surgery

06

What researchers measure

Primary outcomes

  1. Conversion of operation to laparotomy

    The number and frequency will be reported with 95% confidence intervals.

    Time frame: Within 30 days of operation

  2. Incidence of major surgical complications

    Will be assessed by Clavien-Dindo classification as grade 3 or higher. The number and frequency will be reported with 95% confidence intervals.

    Time frame: Within 30 days of operation

07

Study locations

1 of 1 sites recruiting
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010, United States
    • Mehdi Moslemi-kebria · Contact · mkebria@COH.org · 909-949-2242
    • Mehdi Moslemi-kebria · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05672368
Lead sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 5, 2023
Start date
Apr 26, 2024
Primary completion
Oct 13, 2026 (estimated)
Completion
Oct 13, 2026 (estimated)
Last update
Apr 20, 2026

Study contacts

Mehdi Moslemi-Kebria
principal investigator · City of Hope Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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